25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg hard capsules
pregabalin
What Pregabalin Sandoz is and what it is used for
Pregabalin Sandoz belongs to a group of medicines used to treat epilepsy, neuropathic pain, and generalized anxiety disorder in adults.
Peripheral and central neuropathic pain: Pregabalin Sandoz is used to treating long-term pain caused by a nerve injury. Several diseases can cause peripheral neuropathic pain, such as diabetes or shingles. The feeling of pain can be described as hot, burning, throbbing, radiating, stabbing, cutting, cramping, aching, stinging, numbness, and ant crawling. Peripheral and central neuropathic pain can also be associated with mood swings, sleep disorders, and fatigue (fatigue) and can have an impact on physical and social function as well as the overall quality of life.
Epilepsy: Pregabalin Sandoz is used to treating a certain form of epilepsy ( partial epilepsy with or without secondary generalization) in adults. Your doctor will prescribe Pregabalin Sandoz to you to treat your epilepsy as your current treatment does not keep the disease under control. You should take Pregabalin Sandoz as an adjunct to your current treatment. Pregabalin Sandoz is not for use alone but should always be taken in combination with other antiepileptic medicines.
Generalized Anxiety Disorder: Pregabalin Sandoz is used to treat generalized anxiety disorder. The symptoms of generalized anxiety disorder are prolonged excessive anxiety and worry that are difficult to control. Generalized anxiety disorder can also cause restlessness or a feeling of being bloated or tense, that you easily get tired, have concentration problems or episodes of absence, feel irritable, get muscle tension or sleep disturbance. This differs from stress and strain in everyday life.
What you need to know before you take Pregabalin Sandoz
Do not take Pregabalin Sandoz
- if you are allergic to pregabalin or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor or pharmacist before taking Pregabalin Sandoz.
- Some patients treated with pregabalin have reported symptoms suggestive of allergic reactions. These symptoms include swelling of the face, lips, tongue, and throat as well as a diffuse rash. If you experience any of these reactions, contact your doctor immediately.
- Pregabalin has been associated with dizziness and drowsiness, which could increase the incidence of falls in elderly patients. You should therefore be careful until you are used to the effects that the medicine may have.
- Pregabalin Sandoz can cause blurred vision, visual impairment, or another form of visual impairment. Many of these side effects are transient. You should contact a doctor immediately if you experience any change in your vision.
- Some diabetic patients who gain weight during the use of pregabalin may need a change in their diabetes medication.
- Some side effects may be more common, such as drowsiness, as patients with spinal cord injury may take other medicines to treat, for example, pain or spasticity. These medicines have similar side effects to pregabalin and the severity of these side effects may increase when taken together.
- There have been reports of heart failure in some patients taking pregabalin, these patients have mostly been elderly with cardiovascular disease. Before taking this medicine, you should tell your doctor if you have had any heart disease.
- There have been reports of renal failure in some patients taking pregabalin. If you experience any decrease in urine output during treatment with Pregabalin Sandoz, tell your doctor as this may stop if you stop taking the medicine.
- A small number of people who are treated with anti-epileptic drugs such as Pregabalin Sandoz have also had thoughts of harming themselves or committing suicide. If you ever get these thoughts, contact your doctor immediately.
- When Pregabalin Sandoz is taken with other medicines that can cause constipation (such as certain types of painkillers) problems with the gastrointestinal tract may occur (eg constipation, blocked or sluggish bowel). Tell your doctor if you get constipation, especially if you are prone to this problem.
- Before taking this medicine, you should tell your doctor if you have alcoholism or drug abuse, or addiction in your background. Do not take more medicine than prescribed.
- There have been reports of seizures when taking pregabalin or shortly after stopping pregabalin. Contact your doctor immediately if you experience seizures.
- There have been reports of cerebral palsy ( encephalopathy ) in some patients taking pregabalin when they have other conditions. Tell your doctor if you have had a serious medical condition, including liver or kidney disease.
- There have been reports of difficulty breathing. If you have a disease of the nervous or respiratory system, impaired kidney function, or if you are older than 65 years, your doctor may prescribe a different dosing regimen. Contact your doctor if you have difficulty breathing or shallow breathing.
Children and young people
The safety and efficacy of pregabalin in children and adolescents (under 18 years of age) have not been established and therefore pregabalin should not be used in this age group.
Other medicines and Pregabalin Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregabalin Sandoz and some other medicines may interact ( interaction ). When taken with certain other medicinal products that have sedative effects (including opioids ), Pregabalin Sandoz may potentiate these effects, which may lead to impaired breathing, coma, and death. The degree of dizziness, drowsiness, and impaired concentration will be more pronounced if Pregabalin Sandoz is used with medicines containing:
Oxycodone – (used as a painkiller)
Lorazepam – (used to treat anxiety)
Alcohol
Pregabalin Sandoz can be taken at the same time as oral contraceptives ( birth control pills ).
Pregabalin Sandoz with food, drink, and alcohol
Pregabalin Sandoz capsules can be taken with or without food.
Patients are advised not to drink alcohol while taking Pregabalin Sandoz.
Pregnancy and breastfeeding
Pregabalin Sandoz should not be used during pregnancy or breastfeeding unless you have been told otherwise by your doctor. Effective contraception must be used by women of childbearing potential. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Pregabalin Sandoz may cause dizziness, drowsiness, and impaired concentration. You should not drive, operate advanced machinery or engage in any other potentially hazardous activity until you know how this medicine affects your ability to perform these activities.
How to take Pregabalin Sandoz
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Your doctor will decide which dose is right for you.
Pregabalin Sandoz is for oral use only.
Peripheral and central neuropathic pain, epilepsy, or generalized anxiety disorder:
- Take as many capsules as your doctor has told you to.
- The dose, which is tailored for you and your illness, is usually between 150 mg and 600 mg per day.
Your doctor will tell you to take Pregabalin Sandoz either twice a day or 3 times a day. When dosing twice daily, Pregabalin Sandoz should be taken once in the morning and once in the evening, at approximately the same time each day. When dosing three times a day, Pregabalin Sandoz should be taken once in the morning, once in the afternoon, and once in the evening at approximately the same time each day.
If you have the impression that the effect of Pregabalin Sandoz is too strong or too weak, talk to your doctor or pharmacist.
If you are older (over 65 years) you should use Pregabalin Sandoz as normal, but not if you have impaired kidney function.
Your doctor may prescribe a different dosing schedule and/or a different dosage if you have impaired kidney function.
Swallow the capsule whole with water.
Continue to take Pregabalin Sandoz until your doctor tells you to stop.
If you take more Pregabalin Sandoz than you should
Contact a doctor immediately or go to the nearest emergency room. Bring your carton or container of Pregabalin Sandoz capsules. You may feel sleepy, confused, anxious, or restless as a result of taking too much Pregabalin Sandoz. Seizures have also been reported.
If you forget to take Pregabalin Sandoz
It is important to take Pregabalin Sandoz capsules regularly and at the same time each day. If you forget to take a dose, take it as soon as you remember unless it is time for your next dose. In that case, continue with the next dose as usual. Do not take a double dose to make up for a forgotten dose.
If you stop taking Pregabalin Sandoz
Do not stop taking Pregabalin Sandoz unless your doctor tells you to. If your treatment is to be stopped, it should be done gradually for at least a week.
You should know that after abrupt discontinuation of long- and short-term treatment with Pregabalin Sandoz, you may experience certain withdrawal symptoms/side effects. These include sleep problems, headaches, nausea, feelings of anxiety, diarrhea, flu-like symptoms, seizures, nervousness, depression, pain, sweating, and dizziness. If you have been taking Pregabalin Sandoz for a long time, these symptoms may occur more often and be more pronounced.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common: may affect more than 1 user in 10
Dizziness, drowsiness, headache.
Common: may affect up to 1 in 10 users
- Increased appetite
- The feeling of excitement, confusion, disorientation, decreased sexual desire, irritability
- Decreased attention, clumsiness, memory impairment, memory loss, tremor, difficulty speaking, tingling sensation, numbness, fatigue, drowsiness, insomnia, fatigue, feeling abnormal
- Blurred vision, double vision
- Fraud, balance difficulties, falls
- Dry mouth, constipation, vomiting, flatulence, diarrhea, nausea, bloating
- Difficulty getting an erection
- Swelling in the body including arms and legs
- Feeling intoxicated, gait disturbance
- Weight gain
- Muscle cramps, joint pain, back pain, pain in arms and legs
- Sore throat
Uncommon: may affect up to 1 in 100 people
- Decreased appetite, weight loss, low blood sugar, high blood sugar
- Altered self-perception, restlessness, depression, intense anxiety, mood swings, difficulty finding words, hallucinations, abnormal dreams, panic attacks, indifference, aggression, high mood, mental deterioration, difficulty thinking, increased sexual desire, problems with sexual function including the inability to achieve sexual climax, delayed ejaculation
- Vision changes, unusual eye movements, vision changes including tunnel vision, flashes of light, jerky movements, impaired reflexes, hyperactivity, dizziness when standing, sensitive skin, loss of taste, burning sensation, tremor when moving, loss of consciousness, loss of consciousness, fainting, increased sensitivity to sound, numbness
- Dry eyes, eye swelling, eye pain, tired eyes, increased tear flow, eye irritation
- Disorders of heart rhythm, increased heart rate, low blood pressure, high blood pressure, altered heartbeat, heart failure
- Redness, hot flashes
- Difficulty breathing, nasal congestion, nasal congestion
- Increased saliva production, heartburn, numbness around the mouth
- Sweating, rash, chills, fever
- Muscle twitching, joint swelling, muscle stiffness, pain including muscle pain, neck pain
- Sore breasts
- Difficulty urinating or painful urination, incontinence
- Weakness, thirst, feeling of tightness in the chest
- Changes in blood test results and blood tests (increased blood creatinine phosphokinase, increased alanine aminotransferase, increased aspartate aminotransferase, decreased platelet count, neutropenia, increased blood creatinine, decreased blood potassium)
- Hypersensitivity, swelling of the face, itching, hives, runny nose, nosebleeds, cough, snoring
- Painful menstruation
- Cold hands and feet
Rare: may affect up to 1 in 1,000 users
- Abnormal sense of smell, fluctuations in vision, altered depth of field, altered light experience, visual impairment
- Dilated pupils er, squinted
- Cold sweats, tightness in the throat, swelling of the tongue
- Inflammation of the pancreas
- Difficulty swallowing
- Slow or decreased mobility in the body
- Difficulty writing properly
- Increased fluid in the abdomen
- Fluid in the lungs
- Seizures
- Changes in the measured electrical changes in the heart ( ECG ), corresponds to disturbances in the heart rhythm
- Muscle injuries
- Breast secretion, abnormal breast growth, breast growth in men
- Interrupted menstruation
- Kidney failure decreased urine output, difficulty urinating
- Decreased white blood cell count
- Inappropriate behavior
- Allergic reactions (which may include difficulty breathing, inflammation of the eye [keratitis], and a severe skin reaction characterized by itching, blisters, scaly skin, and pain)
- Jaundice (yellowed skin and yellowed eyes)
- Parkinsonism, ie symptoms similar to Parkinson’s disease; such as tremors, bradykinesia (reduced mobility), and rigidity (muscle stiffness).
Very rare: may affect up to 1 in 10,000 people
- Liver failure
- Hepatitis ( inflammation of the liver)
If you experience swelling of the face or tongue or if your skin becomes red and starts to get blisters or scales, contact a doctor immediately.
Some side effects may be more common, such as drowsiness, as patients with spinal cord injury may take other medicines to treat, for example, pain or spasticity. These medicines have similar side effects to pregabalin and the severity of these side effects may increase when taken together.
The following side effects have been reported after the market introduction: difficulty breathing, and shallow breathing.
How to store Pregabalin Sandoz
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister, container, or carton after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
HDPE container: Used within 6 months after first opening.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is pregabalin. Each hard capsule contains 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg or 300 mg of pregabalin.
- The other ingredients are pregelatinized maize starch, maize starch, talc, gelatin, titanium dioxide (E 171), yellow iron oxide (E 172) (all strengths except 150 mg), red iron oxide (E 172) (all strengths except 50 mg and 150 mg), black iron oxide (E 172) (only 25 mg and 300 mg).
What the medicine looks like and the contents of the pack
| 25 mg capsules | Light yellow-brown opaque upper and lower part, capsule size 4 (14.3 mm x 5.3 mm) filled with white to almost white powder. |
| 50 mg capsules | Light yellow opaque upper and lower part, capsule size 3 (15.9 mm x 5.8 mm) filled with white to almost white powder. |
| 75 mg capsules | Red opaque top and white opaque bottom, capsule size 4 (14.3 mm x 5.3 mm) filled with white to almost white powder. |
| 100 mg capsules | Red opaque upper and lower part, capsule size 3 (15.9 mm x 5.8 mm) filled with white to almost white powder. |
| 150 mg capsules | White opaque upper and lower part, capsule size 2 (18.0 mm x 6.4 mm) filled with white to almost white powder. |
| 200 mg capsules | Light orange opaque upper and lower part, capsule size 1 (19.4 x 6.9 mm) filled with white to almost white powder. |
| 225 mg capsules | Light orange opaque top and white opaque bottom, capsule size 1 (19.4 x 6.9 mm) filled with white to almost white powder. |
| 300 mg capsules | The red opaque upper part and light yellow-brown opaque lower part, capsule size 0 (21.7 x 7.6 mm) filled with white to almost white powder. |
Pregabalin Sandoz is available in the following packages:
PVC / PVDC // Alu-blister packed in cardboard.
PVC / PVDC // Alu-unit blisters packed in cardboard.
HDPE container with screw cap made of PP packed in cardboard.
25 mg capsules:
Blisters containing 14, 28, 56, 70, 84, 100, or 120 hard capsules.
Single-dose blisters containing 56 x 1, 84 x 1 or 100 x 1 hard capsules.
HDPE container containing 200 hard capsules.
50 mg capsules:
Blisters containing 14, 21, 28, 56, 84, or 100 hard capsules.
Single-dose blisters containing 84 x 1 hard capsules.
HDPE container containing 200 hard capsules.
75 mg capsules:
Blisters containing 14, 21, 28, 56, 70, 84, 100 or 120 hard capsules.
Single-dose blisters containing 14 x 1, 56 x 1, 84 x 1, 100 x 1 or 210 x 1 (3 x 70) hard capsules.
HDPE containers containing 100, 200 or 250 hard capsules.
100 mg capsules:
Blisters containing 14, 21, 28, 56, 84, or 100 hard capsules.
Single-dose blisters containing 84 x 1 or 100 x 1 hard capsules.
150 mg capsules:
Blisters containing 14, 21, 28, 56, 70, 84, 100 or 120 hard capsules.
Single-dose blisters containing 56 x 1, 84 x 1, 100 x 1 or 210 x 1 (3 x 70) hard capsules.
HDPE containers containing 100, 200 or 250 hard capsules.
200 mg capsules:
Blisters containing 21, 28, 84, or 100 hard capsules.
Single-dose blisters containing 84 x 1 or 100 x 1 hard capsules.
225 mg capsules:
Blisters containing 14, 56, 70, 84, 100, or 120 hard capsules.
300 mg capsules:
Blisters containing 14, 21, 28, 56, 70, 84 (2 x 42), 100, 100 (2 x 50) or 120 (2 x 60) hard capsules.
Single-dose blisters containing 56 x 1, 84 x 1 (2 x 42), 100 x 1, 100 x 1 (2 x 50) or 210 x 1 (3 x 70) hard capsules.
HDPE containers containing 100, 200, or 250 hard capsules.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Austria
Manufacturer
HDPE container:
Lek Pharmaceuticals dd
Verovškova 57
1526 Ljubljana
Slovenia
Blister:
Salutas Pharma GmbH
Otto-von-Guericke Allee 1
D-39179 Barleben
Germany
Contact the representative of the marketing authorization holder to find out more about this medicine:
Sandoz A / S
Edvard Thomsens Vej 14
DK-2300 Copenhagen S
Denmark
Tel: + 45 6395 1000
Info.sverige@sandoz.com